By: Adam Feuerstein | 04/03/14 - 09:00 AM EDT
The biotech sector's March "fluctuation" might be a temporary speed bump or the beginning of a longer downturn. Either way, investors can still count on the biotech catalyst trade for chills and thrills.
I put together a list of biotech catalysts for the second quarter. It's fairly extensive, owing much to April, May and June being the high season for medical conferences.
Take a look.
The most significant catalyst in the second quarter, perhaps the entire year, belongs to Vertex Pharmaceuticals (VRTX) and the TRAFFIC and TRANSPORT phase III studies of Kalydeco and VX-809 in cystic fibrosis patients with the f508del mutation. Vertex has guided to top-line results mid-year, which could mean June but perhaps in May.
Celgene's (CELG) Revlimid Markman hearing is scheduled for April 29.
At the American Thoracic Society annual meeting, (May 16-21), InterMune (ITMN) and Boehringer Ingelheim will be making full data presentations of phase III studies for their competing idiopathic pulmonary fibrosis drugs Esbriet and nintedanib, respectively. Intermune announced positive top-line results from the Esbriet study in XXXX, while some of the Boehringer nintedanib data leaked.
The annual Super Bowl of cancer drug research, otherwise known as the American Society of Clinical Oncology annual meeting, runs May 31 through June 4. Like last year, the big focus will be on cancer immunotherapy, more specifically the "checkpoint inhibitors" or anti-PD1 therapies under development by Bristol-Myers Squibb (BMY), Merck (MRK) and Roche RHHBY. The ASCO meeting is huge, so just about every cancer-focused biotech and drug company will have a presence. I'll throw some stocks out there to give you a taste: Incyte (INCY), Clovis Oncology (CLVS), Oncomed Pharmaceuticals (OMED) and Pharmacyclics (PCYC). Important to note: Research abstracts for the ASCO meeting will be released on May 14.
For the first time in a long time, there's something for investors to see UN-related to hepatitis C at a liver disease meeting. Intercept Pharmaceuticals (ICPT) will present full data from the POISE phase III study of obeticholic acid for the treatment of primary biliary cirrhosis (PBC) at the European Association for the Study of Liver (EASL) meeting, scheduled for April 9-14. Hepatitis C won't be ignored at this year's EASL meeting, of course. Significant data presentations are expected from Merck, Gilead Sciences (GILD) (of course) and Bristol-Myers Squibb, among others. The buzzword for this year's Hep C data presentations is "pan-genotypic" -- meaning drugs (or combinations of drugs) capable of treating all the various Hep C genotypes.
The American Association for Cancer Research annual meeting generally focuses on very early stage research, but noteworthy at this year's meeting (April 5-9) will be phase I data on Agios Pharma's (AGIO) AG-221 in acute myeloid leukemia patients.
Pfizer (PFE) will also be at AACR presenting the PALOMA-1 phase II breast cancer data on palbociclib. The company announced the study's success in February, leading to speculation of an early approval filing.
We'll get an update from Isis Pharma (ISIS) (partnered with Biogen Idec (BIIB)) on the phase II study of SMN-Rx in infants with spinal muscular atrophy at the American Academy of Neurology (AAN) meeting April 26-May 3.
The FDA approval decision date for Mannkind's (MNKD) rapid-acting inhaled insulin Afrezza is April 15.
On March 24, Provectus Biopharmaceuticals (PVCT) announced (strangely) that a request had been filed with FDA to grant breakthrough therapy designation to the melanoma drug PV-10. FDA has 60 days to respond, so expect an announcement from Provectus on or near May 24.
Cytokinetics (CYTK) is looking at two opportunities in the second quarter to announce results from a phase IIB study of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS). The first will be at the AAN meeting (April 26-May 3) or later in the quarter at the Joint Congress of European Neurology (May 31-June 3).
In April or May, Pfizer (PFE) and Athersys (ATHX) will announce top-line data from a phase II study of Multistem in patients with ulcerative colitis.
The FDA approval decision date for Keryx Pharmaceuticals' (KERX)dialysis phosphate binder Zerenex is June 7.
Three days later, on June 10, FDA is expected to announce the approval decision for Orexigen Therapeutics' (OREX) weight-loss therapy Contrave.
When Amgen (AMGN) bought Onyx Pharmaceuticals for $10 billion, the big prize was the multiple myeloma drug Kyprolis. Two important studies of Kyprolis are expected to read out in the second quarter. The FOCUS phase III study compares Kyprolis to best supportive care in multiple myeloma patients who no longer respond to multiple therapies. This study is intended for regulatory approval of Kyprolis in Europe and the rest of the world. The ASPIRE phase III trial compares Kyprolis, Revlimid and dexamethasone to Revlimid and dexamethasone in patients with relapsed multiple myeloma and is the confirmatory overall survival trial meant to support Kyprolis' accelerated approval in the U.S.
Ohr Pharmaceuticals (OHRP) plans an interim analysis in the second quarter of a phase II study of squalamine, an eye-drop medicine for wet age-realted macular degeneration.
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